GM85
K-Number: K222353 · 2022-09-29
Device Summary
Frequently Asked Questions
What is the GM85?
GM85 is a medical device that received FDA 510(k) clearance on 2022-09-29. The listed applicant is Samsung Electronics Co., Ltd.. The 510(k) number is K222353.
When did GM85 receive FDA 510(k) clearance?
GM85 received FDA 510(k) clearance on 2022-09-29, under 510(k) number K222353.
Who is the listed applicant for GM85?
The FDA 510(k) record lists Samsung Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for GM85?
The FDA product code for GM85 is IZL.
Other records listing Samsung Electronics Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: IZL)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.